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510(k) K921511

CATHETER MOUNTS -- MODIFICATION by Intersurgical, Inc. — Product Code BZA

K921511 is an FDA 510(k) premarket notification submitted by Intersurgical, Inc. for the device "CATHETER MOUNTS -- MODIFICATION". The FDA issued a decision of Substantially Equivalent on June 17, 1992. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Intersurgical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1992
Date Received
March 24, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Airway (Extension)
Device Class
Class I
Regulation Number
868.5810
Review Panel
AN
Submission Type

Other clearances by Intersurgical, Inc.

  • K223258 — TNI Clear-Guard™ 3 angled breathing filter (1545020) (June 15, 2023)
  • K122077 — MANOMETER (January 10, 2013)
  • K122075 — DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER (December 20, 2012)
  • K121026 — FLO-GUARD BREATHING FILTER (November 2, 2012)
  • K092451 — INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTE (October 29, 2010)
  • K092129 — INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2 (May 18, 2010)
  • K092409 — HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD (March 10, 2010)
  • K032322 — CLEAR-THERM MICRO HME, MODEL 1441 (May 13, 2004)
  • K024270 — CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH (June 24, 2003)
  • K990949 — CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W (June 15, 1999)

Other clearances for product code BZA

  • K083702 — TRACH-ASSIST (March 5, 2009)
  • K954383 — SURELOC CIRCUIT CONNECTOR (December 22, 1995)
  • K954197 — DISPOSABLE FLEX TUBE (October 26, 1995)
  • K953786 — UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS (September 19, 1995)
  • K952824 — NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR (July 20, 1995)
  • K951345 — DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING (April 14, 1995)
  • K944532 — PRIMA, INC. VENTILATOR HOSES (December 2, 1994)
  • K944535 — PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS (November 29, 1994)
  • K944534 — PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS (November 29, 1994)
  • K942392 — AIRWAY CONNECTOR WITH FLEX TUBE (August 22, 1994)

FDA data resources